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FDA establishment 1000513191, Brockton, Massachusetts, United States. Part of Lyne Laboratories's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 9
Official action indicated: 1
Last inspection ended: Mar 10, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.122(a). Sampling/testing of labeling/packaging materials Labeling and packaging materials are not representatively sampled, examined and tested upon receipt and before use in packaging and labeling of a drug product.
21 CFR 211.58. Buildings not maintained in good state of repair Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 211.84(b). Representative Samples Representative samples are not taken of each shipment of each lot of drug product containers and closures for testing or examination.
Voluntary Action Indicated (VAI)
Oct 21, 2022
Drugs · Drug Quality Assurance
7 cited references
21 CFR 211.160(a). Following/documenting laboratory controls Established laboratory control mechanisms are not followed.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
21 CFR 211.58. Buildings not maintained in good state of repair Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Voluntary Action Indicated (VAI)
Jan 25, 2018
Drugs · Drug Quality Assurance
3 cited references
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Voluntary Action Indicated (VAI)
Sep 7, 2017
Drugs · Bioresearch Monitoring
None posted
No Action Indicated (NAI)
Aug 17, 2016
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Feb 13, 2014
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Mar 25, 2011
Drugs · Drug Quality Assurance
7 cited references
21 CFR 211.194(b). Test method modification records do not include Records maintained of any modification of an established method employed in testing do not include the reason for the modification and the data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established method.
21 CFR 211.186(b)(9). Complete instructions, procedures, specifications et. al. Master production and control records lack complete manufacturing and control instructions.
21 CFR 211.68(b). Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
21 CFR 211.182. Specific information required in individual logs Individual equipment logs do not show time, date, product, and lot number of each batch processed.
21 CFR 211.160(a). Lab controls established, including changes The establishment of test procedures and laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit.
21 CFR 211.194(a)(4). Complete Test Data Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Voluntary Action Indicated (VAI)
Apr 5, 2010
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Feb 26, 2009
Drugs · Drug Quality Assurance
14 cited references
21 CFR 211.180(e)(1). Review of representative number of batches Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
21 CFR 211.160(b)(3). Drug products - samples representative, identified properly Samples taken of drug products for determination of conformance to written specifications are not representative and properly identified.
21 CFR 211.110(d). Rejected in-process materials not quarantined Rejected in-process materials are not identified to prevent their use in manufacturing or processing operations for which they are unsuitable.
21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
21 CFR 211.84(c)(3). Sterile/Aseptic Techniques for Sampling Sampling procedures are deficient regarding sterile equipment and aseptic sampling techniques when sampling components.
21 CFR 211.56(c). Written procedures lacking for use of pesticides etc. Written procedures are lacking for the use of insecticides designed to prevent the contamination of components and drug products.
21 CFR 211.52. Washing and toilet facilities are deficient Washing and toilet facilities lack hot and cold water.
21 CFR 211.46(b). Equipment for Environmental Control Equipment for adequate control over humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine calibration of automatic equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
21 CFR 211.22(c). Approve or reject procedures or specs The quality control unit lacks responsibility to reject all procedures or specifications impacting on the quality of drug products.
21 CFR 211.192. Extent of discrepancy, failure investigations Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Brockton, Massachusetts, United States. Part of